US officials 'knew of Vioxx threat',,175-1301741,00.html
 October 09, 2004 The Times

From James Doran, Wall Street Correspondent
   VITAL research into the potential dangers of taking Vioxx, the arthritis
drug withdrawn because it can cause heart attacks and strokes, was kept
under wraps by US government regulators, according to a whistleblower.

It has also emerged that senior officials at the US Food and Drug
Administration, which regulates the sale of medicines, sought to work with
Merck, the US manufacturer of Vioxx, to minimise and sort out the damage
that the research would inevitably cause.

E-mails sent by officials at the FDA claim that Merck was under the
impression that it had a "special agreement" with the agency that would
allow the company to be advised of any damaging research about their
products before the public was warned.

Other e-mails, obtained by The Times, show that FDA officials tried to tone
down research advising that those taking Vioxx could be seriously affected.
Merck pulled Vioxx off the shelves last week and revealed that it can cause
fatal heart attacks and debilitating strokes in arthritis patients who were
otherwise healthy.

David Graham, one of the top scientists at the FDA, was asked to research
Vioxx in May 2001. By August 2004 he was ready to present his damning
conclusions to a conference in France but the FDA tried to gag him, Dr
Graham claims. His allegations were revealed during an interview on
Thursday with officials from the US Senate Finance Committee, headed by
Senator Chuck Grassley, who has been investigating the FDA.

"David Graham in his capacity as a staff researcher at the FDA did research
that raised serious questions about Vioxx and its detrimental effect on
health," Mr Grassley said. "He wants to make it public, as is the FDA's
mission statement. Now we find that people at the FDA tried to block
publication of his memorandum and made Dr Graham about as welcome as a
skunk at a picnic."

Dr Graham handed over a file of e-mails about the Vioxx tests that were
sent by his FDA superiors. One was sent in response to his request to make
his findings about the dangers public by labelling the drug with a warning.
It stated: "I still think this is pretty strong language since to my
knowledge FDA is not contemplating such a warning for labelling."

Another e-mail suggests that the FDA wanted to prepare Merck for the bad
publicity were Dr Graham's research to be published before it warned the
public of the dangers of Vioxx. Both e-mails were written this August, over
a month before Merck took the drug from the shelves.

None of those mentioned in the e-mails and memos at the FDA claimed to know
about the alleged special agreement with the manufacturer.

The FDA said it had followed normal procedures with Dr Graham and the
research into Vioxx but would not comment about the internal e-mails or
allegations. It added that after Dr Graham had completed his research it
was handed to other researchers for further investigation. Dr Graham
"transmitted his completed report to his agency supervisors on September
30. The standard agency review process for this type of report is a more
rigorous scientific peer review," an FDA statement said.